Management method for a sample processing apparatus

ABSTRACT

A managing method for a sample processing apparatus involving the sample processing apparatus and a management apparatus. The method includes requesting an approval of self-adjustment to the management apparatus from the sample processing apparatus before performing a self-adjustment. Informing the sample processing apparatus of approval of request from the management apparatus, when approving the sample processing apparatus to perform the self-adjustment, and performing a self-adjustment by the sample processing apparatus when the sample processing apparatus is informed that the request has been approved.

RELATED APPLICATIONS

This application is a divisional patent application of U.S. applicationSer. No. 13/752,882, filed Jan. 29, 2013, which is a continuation ofPCT/JP2011/004176 filed on Jul. 25, 2011, which claims priority toJapanese Application No. 2010-172958 filed on Jul. 30, 2010. The entirecontents of these applications are incorporated herein by reference.

BACKGROUND

The present invention relates to management systems for sampleprocessing apparatuses which process clinical samples such as blood andurine, sample processing apparatuses and management apparatuses, andmanagement methods.

There are known sample processing apparatuses which process samples,such as blood cell counters, blood coagulation measurement apparatuses,immunoassay apparatuses, gene amplification measurement apparatuses,urine qualitative analyzers, urine formed element analyzers, biochemicalanalyzers, and blood smear preparation apparatuses. When abnormality hasoccurred in such a sample processing apparatus, there may be a casewhere a technician in charge of maintenance has to take a countermeasureagainst the abnormality.

Japanese Laid-Open Patent Publication No. 2004-286663 discloses anautomatic analyzer in which when abnormality has occurred in theautomatic analyzer, a notification e-mail is generated and thenotification e-mail is transmitted to the person in charge. The e-mailtransmitted from this automatic analyzer includes information, such asthe data under analysis and the analysis condition, as a message or anattached file. The person in charge reads this e-mail by using, forexample, a personal computer, a mobile phone, or a personal digitalassistant, understands the status of the automatic analyzer and thestate of the fault that occurred, and transmits a reply mail to thenotification e-mail, the reply mail containing a command for causing theautomatic analyzer to perform an operation for taking a countermeasureagainst the failure. An automatic analyzer 1 performs the operation fortaking a countermeasure against the failure, by extracting the commandfrom the received reply mail and performing the command. Examples ofoperations for taking countermeasures against failures disclosed inJapanese Laid-Open Patent Publication No. 2004-286663 includeperforming, after analysis is resumed and analysis condition has becomestable, analysis from the beginning again, column cleaning, removingbubbles, preprocessing, and the like.

SUMMARY

However, in the automatic analyzer described in Patent Literature 1above, the person in charge needs to examine a countermeasure againstthe failure and transmit a command for an operation as a countermeasureby an e-mail, which is a great burden on the person in charge. Further,there are individual differences among automatic analyzers, and optimumset values are different in each automatic analyzer. However, in PatentLiterature 1 described above, it is difficult for the person in chargewho is in a remote place to designate set values unique to the automaticanalyzer in which the failure has occurred. Further, it is difficult torestore the automatic analyzer from the failure that requires adjustmentof values to set values that are different in each automatic analyzer.

The present invention has been made in view of the above problem. A mainobject of the present invention is to provide a sample processingapparatus management system, sample processing apparatuses, a managementapparatus, and a management method that can accurately and easily adjustthe respective sample processing apparatuses irrespective of theirindividual differences.

In order to solve the problems described above, a sample processingapparatus management system according to an aspect of the presentinvention is a sample processing apparatus management system comprising:a sample processing apparatus which processes samples; and a managementapparatus communicably connected to the sample processing apparatus, thesample processing apparatus comprising: a self-adjustment section whichperforms self-adjustment; and a first communication section whichrequests an approval of the self-adjustment, before the self-adjustmentby the self-adjustment section is performed, the management apparatuscomprising: a determination section which determines whether to approvethe request; and a second communication section which informs, whenapproving the request to perform the self-adjustment, the sampleprocessing apparatus of approval of the request, wherein the sampleprocessing apparatus is configured to perform, when informed that therequest has been approved, the self-adjustment by the self-adjustmentsection.

In this aspect, the sample processing apparatus may further include anevent detection section which detects an event for starting theself-adjustment by the self-adjustment section, and the firstcommunication section may be configured to request the approval when theevent detection section has detected the event.

In the above aspect, the sample processing apparatus may further includean abnormality detector which detects abnormality in the sampleprocessing apparatus, and the event detection section may be configuredto detect, as the event, the detection of the abnormality by theabnormality detector.

In the above aspect, the sample processing apparatus may further includea type determination section which determines a type of the eventdetected by the event detection section, the first communication sectionmay be configured to request the approval when the type determinationsection has determined that the type of the event detected by the eventdetection section is a first type, and configured not to request theapproval when the type determination section has determined that thetype of the event detected by the event detection section is a secondtype which is different from the first type, and the sample processingapparatus may be configured such that, in a case where the typedetermination section has determined that the type of the event detectedby the event detection section is the first type, the sample processingapparatus performs the self-adjustment by the self-adjustment sectionwhen informed that the request has been approved, and in a case wherethe type determination section has determined that the type of the eventdetected by the event detection section is the second type, the sampleprocessing apparatus performs the self-adjustment by the self-adjustmentsection, without waiting for the approval.

In the above aspect, the sample processing apparatus may further includean adjustment value generation section which generates an adjustmentvalue for the sample processing apparatus, and the self-adjustmentsection may be configured to perform the self-adjustment of the sampleprocessing apparatus to the adjustment value generated by the adjustmentvalue generation section.

In the above aspect, the sample processing apparatus may furtherinclude: a measurement unit which measures samples; a memory in whichcalibration information for calibrating a measurement result is stored;and a conversion section which converts a measurement result obtained bythe measurement unit, based on the calibration information stored in thememory, the adjustment value generation section may be configured togenerate calibration information as the adjustment value for the sampleprocessing apparatus, based on a measurement result obtained by themeasurement unit measuring a calibration information generationspecimen, and the self-adjustment section may be configured to performthe self-adjustment of the sample processing apparatus, by storing inthe memory the calibration information generated by the adjustment valuegeneration section.

In the above aspect, the sample processing apparatus may further includean operation mechanism whose position can be adjusted and which performsan operation regarding sample measurement, the adjustment valuegeneration section may be configured to generate a position adjustmentamount for the operation mechanism as the adjustment value for thesample processing apparatus, and the self-adjustment section may beconfigured to perform the self-adjustment of the sample processingapparatus by adjusting the position of the operation mechanism based onthe position adjustment amount generated by the adjustment valuegeneration section.

In the above aspect, the operation mechanism may be configured to beable to move to a specific position for sample measurement, and theadjustment value generation section may be configured to generate theposition adjustment amount for positioning the operation mechanism atthe specific position.

In the above aspect, the operation mechanism may be a dispensingmechanism which moves to an aspirating position for aspirating a sampleor a reagent and aspirates the sample or the reagent, and which moves toa discharging position for discharging a sample or a reagent anddischarges the sample or the reagent.

In the above aspect, the first communication section may be configuredto request the approval with transmitting specifying information forspecifying a user who uses the sample processing apparatus, and thedetermination section may be configured to determine whether to approvethe request, based on the specifying information.

In the above aspect, the first communication section may be configuredto request the approval with transmitting the adjustment value generatedby the adjustment value generation section, and the determinationsection may be configured to determine whether to approve the request,based on the adjustment value.

Further, a sample processing apparatus according to an aspect of thepresent invention is a sample processing apparatus which is communicablyconnected to a management apparatus and which processes samples, thesample processing apparatus including: a self-adjustment section whichperforms self-adjustment; and a communication section which requests, tothe management apparatus, an approval of the self-adjustment, before theself-adjustment by the self-adjustment section is performed, wherein thesample processing apparatus is configured to perform, when informed thatrequest has been approved, the self-adjustment by the self-adjustmentsection.

Further, a management apparatus according to an aspect of the presentinvention is a management apparatus communicably connected to a sampleprocessing apparatus which processes samples, the management apparatusincluding: a determination section which determines, when an approval ofa self-adjustment has been requested from the sample processingapparatus, whether to approve the request; and a communication sectionwhich informs, when the determination section has determined to approvethe request, the sample processing apparatus of approval of the request.

Further, a management method according to an aspect of the presentinvention is a managing method for a sample processing apparatus byusing the sample processing apparatus and a management apparatus, themethod including: requesting, before performing self-adjustment, anapproval of self-adjustment to the management apparatus from the sampleprocessing apparatus; informing, when approving the sample processingapparatus to perform the self-adjustment, the sample processingapparatus of approval of request, from the management apparatus; andperforming self-adjustment by the sample processing apparatus when thesample processing apparatus is informed that the request has beenapproved

In the above aspect, the management method may further include an eventdetection step of the sample processing apparatus detecting an event forstarting the self-adjustment, wherein the request of approval is madewhen the event has been detected.

In the above aspect, the event detection step may be configured toinclude a step of detecting, as the event, abnormality in the sampleprocessing apparatus.

In the above aspect, the management method may further include adetermination step of the sample processing apparatus determining a typeof the event detected in the event detection step, wherein theself-adjustment step may be configured to perform, when the type of theevent is a type of an event for which the self-adjustment should beperformed without waiting for the approval, the self-adjustment withoutwaiting for the approval.

According to the management system, the sample processing apparatusesand the management apparatus, and the management method according to thepresent invention, it is possible to accurately and easily adjust therespective sample processing apparatuses irrespective of theirindividual differences, compared to conventional ones.

BRIEF DESCRIPTION OF THE DRAWING

FIG. 1 is a schematic diagram showing a configuration of a managementsystem according to embodiment 1.

FIG. 2 is a perspective view showing a structure of a sample analyzeraccording to embodiment 1.

FIG. 3 is a plan view showing a schematic configuration of the inside ofa measurement unit, seen from above.

FIG. 4 is a side view showing a structure of a first reagent dispensingunit.

FIG. 5 is a perspective view showing a structure of a portion of an arm.

FIG. 6 is a block diagram showing a circuit configuration of ameasurement unit.

FIG. 7 is a block diagram showing a configuration of an informationprocessing unit.

FIG. 8 is a block diagram showing a configuration of a managementserver.

FIG. 9 is a flow chart showing the flow of a calibration operationperformed in the management system according to embodiment 1.

FIG. 10 is a flow chart showing the flow of a pipette positionadjustment operation performed in the management system according toembodiment 1.

FIG. 11 is a flow chart showing a procedure of an adjustment amountdetection process.

FIG. 12 is a schematic diagram showing an image of a cuvette when apipette has not been displaced.

FIG. 13 is a schematic diagram showing an example of an image of acuvette when a pipette has been displaced.

FIG. 14 is a flow chart showing the flow of a self-adjustment operationperformed in a sample processing apparatus according to embodiment 2.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Hereinafter, preferred embodiments of the present invention will bedescribed with reference to the drawings.

Embodiment 1

[Configuration of Management System]

FIG. 1 is a schematic diagram showing a configuration of a managementsystem 1 according to the present embodiment. The management system 1includes sample analyzers 2, 2, . . . , provided in a user facility suchas a hospital or a test center, and a management server 5 provided in amaintenance service provider facility such as a manufacturer of thesample analyzers 2 that performs maintenance of the sample analyzers 2.The sample analyzers 2, 2, . . . and the management server 5 aredata-communicably connected to each other via a communication networksuch as the Internet or dedicated lines. Further, the management server5 is data-communicably connected, via a LAN, to a plurality of clientapparatuses 6 that are used by technicians of the maintenance serviceprovider.

<Configuration of Sample Analyzer>

FIG. 2 is a perspective view showing a structure of the sample analyzer2 according to the present embodiment. The sample analyzer 2 includes ameasurement unit 3 which performs optical measurement on componentscontained in a clinical sample (blood), and an information processingunit 4 which analyzes measurement data obtained by the measurement unit3 and provides operation instructions to the measurement unit 3.

FIG. 3 is a plan view showing a schematic configuration of the inside ofthe measurement unit 3, seen from above. The measurement unit 3 includesa measurement section 10, a detection unit 40, and a transporting unit50.

The measurement section 10 includes a first reagent table 11, a secondreagent table 12, a first container rack 13, a second container rack 14,a cuvette table 15, a heating table 16, a table cover 17, a first sampledispensing unit 21, a second sample dispensing unit 22, a first reagentdispensing unit 23, a second reagent dispensing unit 24, a third reagentdispensing unit 25, a first catcher unit 26, a second catcher unit 27, athird catcher unit 28, a reagent bar code reader 31, a cuvettetransporter 32, a diluent transporter 33, a cuvette hole 34, anddisposal holes 35 and 36.

Each of the first reagent table 11, the second reagent table 12, thecuvette table 15, and the heating table 16 is a circular table, and isindependently and rotationally driven in both clockwise andcounter-clockwise directions. These tables are rotationally driven by aplurality of stepping motors (not shown), respectively, that areprovided on the rear side of the bottom of the measurement unit.

As shown in FIG. 3, five first container racks 13 are removably providedon the top surface of the first reagent table 11, and five secondcontainer racks 14 are removably provided on the top surface of thesecond reagent table 12. Holders for holding reagent containers areformed in each of the first container racks 13 and the second containerracks 14. A bar code label is attached to each of the reagent containersheld in the first reagent table 11 and the second reagent table 12. Onthe bar code label, printed is a bar code which stores reagentinformation such as the type of the reagent, the lot number, theexpiration date, and the like. The bar code of each reagent container isread by the bar code reader 31.

As shown in FIG. 3, each of the cuvette table 15 and the heating table16 is provided with a plurality of cuvette holding holes 15 a (16 a),along the periphery thereof. After cuvettes are set in the cuvetteholding holes 15 a (16 a), the cuvettes are to be moved, in accordancewith the rotation of the cuvette table 15 (the heating table 16), alongthe periphery thereof. The heating table 16 heats cuvettes set in theholding holes 16 a, at a predetermined temperature.

FIG. 4 is a side view showing a structure of the first reagentdispensing unit 23. As shown in FIG. 4, the first reagent dispensingunit 23 includes a driving section 23 a, an arm 23 b, and a pipette 23c. The driving section 23 a includes a rotation motor 231, anascent/descent motor 232, and a transmission mechanism 234 whichtransmits power of the rotation motor 231 and the ascent/descent motor232 to a shaft 233. The transmission mechanism 234 includes: a belttransmission mechanism, a gear mechanism, or the like that decreases therotation power of the rotation motor 231 and transmits the resultantpower to the shaft 233; and a belt transmission mechanism, arack-and-pinion mechanism, or the like that converts the rotation powerof the ascent/descent motor 232 to linear power in the up-down directionand transmits the resultant power to the shaft 233. The rotationdirection and the rotation amount of the rotation motor 231 is detectedby a rotary encoder 235, and the rotation direction and the rotationamount of the ascent/descent motor 232 (that is, the up-down movingdirection and the up-down moving amount of the pipette 23 c) is detectedby a rotary encoder 236.

FIG. 5 is a perspective view showing a structure of a portion of the arm23 b. FIG. 5 shows the arm 23 b whose inside is exposed by removing itstop cover (shown by two-dot chain lines). A pipette P is supported bythe arm 23 b so as to be able to move (slide) in the up-down direction,and downward movement of the pipette P is restricted to a predeterminedrange. Further, the pipette P is under downward force from aforce-applying member 171 composed of a helical compression spring. Thearm 23 b is provided with a base 172 which is movable in the up-downdirection along with the pipette P. A detection member 173 is mounted onthe base 172. The arm 23 b is provided with a circuit board 174 so as tostand therein, and a collision detection sensor 170 is attached to thecircuit board 174.

The collision detection sensor 170 includes a transmissive sensor thathas a phototransmitter and a photoreceiver. The detection member 173 isprovided with a light blocking plate 173 a arranged between thephototransmitter and the photoreceiver of the collision detection sensor170. The light blocking plate 173 a blocks light in the collisiondetection sensor 170 in a normal state, thereby setting the collisiondetection sensor 170 to an off state. When the pipette P descends andcollides with an obstacle, the pipette P is raised relative to the arm23 b, and the light blocking plate 173 a is also raised via the base172, whereby blocking light in the collision detection sensor 170 iscanceled. Accordingly, when the collision detection sensor 170 is turnedon, a measurement controller 140 detects that the pipette P has collidedwith an obstacle.

The first reagent dispensing unit 23 includes a camera 23 d whichincludes an imaging sensor such as a CCD. The camera 23 d is attached toan end of the arm 23 b and can take an image of an area therebelowincluding the pipette P. Since the camera 23 d is fixed to the arm 23 b,even when the arm 23 b is moved, the positional relationship between thecamera 23 d and the pipette P is not changed, whereby the camera 23 d isallowed to take an image of an area always including the tip of thepipette P.

It should be noted that the configurations of the first sampledispensing unit 21, the second sample dispensing unit 22, the secondreagent dispensing unit 24, and the third reagent dispensing unit 25 aresimilar to that of the first reagent dispensing unit 23, and thus,description thereof will be omitted.

With reference back to FIG. 3, the first catcher unit 26 includes: asupport 26 a which supports an arm 26 b; the arm 26 b which is able toextend/contract; and a grip portion 26 c. The support 26 a isrotationally driven by a stepping motor (not shown) provided on the rearside of the bottom of the measurement unit. The grip portion 26 c isattached to the tip of the arm 26 b, and can grip a cuvette. It shouldbe noted that the second catcher unit 27 is also configured similarly tothe first catcher unit 26, and is rotated by a stepping motor (notshown).

As shown in FIG. 3, the third catcher unit 28 includes: a support 28 awhich supports an arm 28 b; the arm 28 b which is able toextend/contract; and a grip portion 28 c attached to the tip of the arm28 b. The support 28 a is driven along a rail arranged in the left-rightdirection. The grip portion 28 c can grip a cuvette.

The cuvette transporter 32 and the diluent transporter 33 are driven inthe left-right direction on rails, respectively. Further, the cuvettetransporter 32 is provided with holes for holding cuvettes and thediluent transporter 33 is provided with holes for holding diluentcontainers.

The cuvette hole 34 is always supplied with a new cuvette. A new cuvetteis set in a hole for holding a cuvette in the cuvette transporter 32 ora cuvette holding hole 15 a in the cuvette table 15, by the firstcatcher unit 26 or the second catcher unit 27, respectively. Thedisposal holes 35 and 36 are holes into which cuvettes are discarded forwhich analyses have been ended and which are no more needed.

Twenty holding holes 41 for holding cuvettes are formed in the topsurface of the detection unit 40. A detector (not shown) is provided onthe rear side of the bottom of the detection unit 40. When a cuvette isset in a holding hole 41, optical information of the measurementspecimen in the cuvette is detected by the detector.

The transporting unit 50 includes a transport path 51, and a sample barcode reader 52. A pre-analysis rack holding area is provided on a rightportion, a transportation area is provided in the middle, and apost-analysis rack holding area is provided on a left portion, on thebottom surface of the transport path 51. The transport path 51 is formedin a U-shape. The sample bar code reader 52 reads the bar code of a barcode label attached to a sample container 61 accommodated in a samplerack 60 being transported in the transportation area.

FIG. 6 is a block diagram showing a circuit configuration of themeasurement unit 3.

The measurement unit 3 includes a controller 300, the reagent bar codereader 31, the sample bar code reader 52, a reagent table stepping motorsection 311, a dispensing unit stepping motor section 312, a cuvettetable stepping motor 313, a heating table stepping motor 314, a catcherunit stepping motor section 315, a reagent table rotary encoder section321, a dispensing unit rotary encoder section 322, a collision detectionsensor section 323, a reagent table origin sensor section 331, adispensing unit origin sensor section 332, and an imaging section 324.The controller 300 includes a CPU 301, a ROM 302, a RAM 303, a hard disk304, a communication interface 305, and an I/O interface 306.

The CPU 301 executes computer programs stored in the ROM 302 andcomputer programs loaded onto the RAM 303. The RAM 303 is used forreading computer programs stored in the ROM 302 and the hard disk 304.Further, the RAM 303 is also used as a work area for the CPU 301 whenthe CPU 301 executes these computer programs. Various computer programsto be executed by the CPU 301 and data used in the execution of thecomputer programs, such as an operating system and application programs,are installed in the hard disk 304. That is, control programs forcausing the CPU 301 to control sections of the measurement unit 3 areinstalled in the hard disk 304. Further, the communication interface 305allows data to be transmitted/received to/from the informationprocessing unit 4.

Further, the CPU 301 controls, via the I/O interface, the reagent barcode reader 31, the sample bar code reader 52, the reagent tablestepping motor section 311, the dispensing unit stepping motor section312, the reagent table rotary encoder section 321, the dispensing unitrotary encoder section 322, the collision detection sensor section 323,the reagent table origin sensor section 331, and the dispensing unitorigin sensor section 332.

The reagent table stepping motor section 311 includes a plurality ofstepping motors that rotationally drive the first reagent table 11 andthe second reagent table 12 independently of each other. The dispensingunit stepping motor section 312 includes the rotation motor 231 and theascent/descent motor 232 of the first reagent dispensing unit 23described above, and respective rotation motors and ascent/descentmotors of the first sample dispensing unit 21, the second sampledispensing unit 22, the second reagent dispensing unit 24, and the thirdreagent dispensing unit 25. These rotation motors and ascent/descentmotors are stepping motors.

The cuvette table stepping motor 313 is implemented by a stepping motorthat rotationally drives the cuvette table 15. The heating tablestepping motor 314 is implemented by a stepping motor that rotationallydrives the heating table 16. The catcher unit stepping motor section 315includes a plurality of stepping motors that respectively rotate thefirst catcher unit 26 and the second catcher unit 27.

The reagent table rotary encoder section 321 includes a plurality ofrotary encoders that can respectively and individually detect rotationdirections and rotation amounts of the plurality of stepping motorsincluded in the reagent table stepping motor section 311. The reagenttable origin sensor section 331 includes a plurality of origin sensorsthat respectively and individually detect that rotational positions ofthe plurality of stepping motors included in the reagent table steppingmotor section 311 are at their origin positions. By receiving outputsignals from the reagent table rotary encoder section 321 and thereagent table origin sensor section 331, the CPU 301 can recognize howmany degrees each of the first reagent table 11 and the second reagenttable 12 has rotated in the clockwise direction or counter-clockwisedirection from its origin position.

The dispensing unit rotary encoder section 322 includes the rotaryencoders 235 and 236 of the first reagent dispensing unit 23 describedabove and respective rotary encoders of the first sample dispensing unit21, the second sample dispensing unit 22, the second reagent dispensingunit 24, and the third reagent dispensing unit 25. That is, thedispensing unit rotary encoder section 322 includes a plurality ofrotary encoders that can respectively and individually detect rotationdirections and rotation amounts of the plurality of stepping motorsincluded in the dispensing unit stepping motor section 312. Thedispensing unit origin sensor section 332 includes a plurality of originsensors that respectively and individually detect that rotationalpositions of the plurality of stepping motors included in the dispensingunit stepping motor section 312 are at their origin positions. Byreceiving output signals from the dispensing unit rotary encoder section322 and the dispensing unit origin sensor section 332, the CPU 301 canrecognize how many degrees each of the arm 21 b, 22 b, 23 b, 24 b, and25 b of the first sample dispensing unit 21, the second sampledispensing unit 22, the first reagent dispensing unit 23, the secondreagent dispensing unit 24, and the third reagent dispensing unit 25 hasrotated in the clockwise direction or counter-clockwise direction fromits origin position in the rotation direction, and how much the arm hasmoved upward or downward from its origin position (reference height) inthe height direction.

Further, the collision detection sensor section 323 includes thecollision detection sensor 170 of the first reagent dispensing unit 23described above and respective collision detection sensors of the firstsample dispensing unit 21, the second sample dispensing unit 22, thesecond reagent dispensing unit 24, and the third reagent dispensing unit25. By receiving output signals from the collision detection sensorsection 323, the CPU 301 can recognize whether each of the pipette 21 c,22 c, 23 c, 24 c, and 25 c of the first sample dispensing unit 21, thesecond sample dispensing unit 22, the first reagent dispensing unit 23,the second reagent dispensing unit 24, and the third reagent dispensingunit 25 has collided with an obstacle.

Further, the imaging section 324 includes the camera 23 d of the firstreagent dispensing unit 23 described above and respective cameras of thefirst sample dispensing unit 21, the second sample dispensing unit 22,the second reagent dispensing unit 24, and the third reagent dispensingunit 25. The CPU 301 can receive an output signal (image signal) fromeach of the cameras included in the imaging section 324.

FIG. 7 is a block diagram showing a configuration of the informationprocessing unit 4.

The information processing unit 4 is implemented by a personal computer,and includes a body 400, an input unit 408, and a display unit 409. Thebody 400 includes a CPU 401, a ROM 402, a RAM 403, a hard disk 404, areadout device 405, an input/output interface 406, an image outputinterface 407, and a communication interface 410.

The CPU 401 executes computer programs stored in the ROM 402 andcomputer programs loaded onto the RAM 403. The RAM 403 is used forreading computer programs stored in the ROM 402 and the hard disk 404.Further, the RAM 403 is also used as a work area for the CPU 401 whenthe CPU 401 executes these computer programs.

Various computer programs to be executed by the CPU 401 and data used inthe execution of the computer programs, such as an operating system andapplication programs, are installed in the hard disk 404. That is,computer programs for causing the computer to function as an informationprocessing apparatus according to the present embodiment are installedin the hard disk 404.

Further, a calibration curve used in calibration of sample measurementdata described later is stored for each measurement item in the harddisk 404.

The readout device 405 is implemented by a CD drive, a DVD drive, or thelike, and can read out computer programs and data stored in a storagemedium. The input unit 408 implemented by a mouse and a keyboard isconnected to the input/output interface 406, and by a user using theinput unit 408, data is inputted in the information processing unit 4.The image output interface 407 is connected to the display unit 409implemented by a CRT, a liquid crystal panel, or the like, and outputsvideo signals in accordance with image data, to the display unit 409.The display unit 409 displays an image, based on the inputted videosignals. The communication interface 410 allows the informationprocessing unit 4 to transmit/receive data to/from the measurement unit3, the management server 5, and the client apparatus 6.

<Configuration of Management Server>

FIG. 8 is a block diagram showing a configuration of the managementserver 5.

The management server 5 is implemented by a personal computer, andincludes a body 500, an input unit 508, and display unit 509. The body500 includes a CPU 501, a ROM 502, a RAM 503, a hard disk 504, a readoutdevice 505, an input/output interface 506, an image output interface507, and a communication interface 510.

The CPU 501 executes computer programs stored in the ROM 502 andexecutes computer programs loaded onto the RAM 503. The RAM 503 is usedfor reading out computer programs stored in the ROM 502 and the harddisk 504. Further, the RAM 503 is also used as a work area for the CPU501 when the CPU 501 executes these computer programs.

Various computer programs to be executed by the CPU 501 and data used inexecution of the computer programs, such as an operating system andapplication programs, are installed in the hard disk 504. That is,computer programs for causing the computer to function as a managementserver according to the present embodiment are installed in the harddisk 504.

The readout device 505 is implemented by a CD drive, a DVD drive, or thelike, and can read out computer programs and data stored in a storagemedium. The input unit 508 implemented by a mouse and a keyboard isconnected to the input/output interface 506, and by a user using theinput unit 508, data is inputted in the management server 5. The imageoutput interface 507 is connected to the display unit 509 implemented bya CRT, a liquid crystal panel, or the like, and outputs video signals inaccordance with image data, to the display unit 509. The display unit509 displays an image, based on the inputted video signals. Thecommunication interface 510 allows the management server 5 totransmit/receive data to/from the sample analyzer 2 and the clientapparatus 6.

<Configuration of Client Apparatus>

The client apparatus 6 is implemented by a personal computer. Theconfiguration of the client apparatus 6 is the same as that of theinformation processing unit 4 described above, except that not computerprograms for causing the computer to function as the informationprocessing unit 4, but computer programs for causing the computer tofunction as a client apparatus that accesses the management server andthat is used to perform maintenance management operation for the sampleanalyzer 2 are installed in the hard disk. Therefore, descriptionthereof will be omitted.

[Operation of Management System]

Hereinafter, operations performed by the management system according tothe present embodiment will be described.

<Analysis Procedure for Each Sample>

First, an analysis procedure for a sample performed by the sampleanalyzer 2 will be described. The analysis procedure for a samplediffers depending on the measurement items (PT, APTT, etc.) for thesample. The measurement items for the sample are specified by ameasurement order. In the sample analyzer 2, it is possible for a userto register a measurement order, and also possible to receive ameasurement order from a host computer not shown. That is, in the casewhere the user registers a measurement order, the user inputs themeasurement order in the sample analyzer 2 by operating the input unit408 of the information processing unit 4. In the case where ameasurement order is received from the host computer, the user registersin advance the measurement order in the host computer.

A sample rack 60 accommodating a plurality of the sample containers 61is set by the user in the pre-analysis rack holding area of thetransport path 51. The sample rack 60 is moved rearward in thepre-analysis rack holding area, and then moved leftward in thetransportation area. At this time, the bar code label attached to eachsample container 61 is read by the sample bar code reader 52. A sampleID is stored in the bar code of each sample container 61. By using theread sample ID as a key, the information processing unit 4 obtains themeasurement order of the sample from the host computer (not shown)connected thereto via a communication network.

Subsequently, the sample rack 60 is located at a predetermined positionin the transportation area. When aspiration of the samples ends in thetransportation area, the sample rack 60 is moved leftward in thetransportation area, and then moved forward in the post-analysis rackholding area.

The first sample dispensing unit 21 aspirates a sample in a samplecontainer 61 located at a predetermined sample aspirating position 53 inthe transportation area of the transport path 51. The sample aspiratedby the first sample dispensing unit 21 is discharged into a cuvette setin a cuvette holding hole 15 a located at a sample discharging position18 which is at a front position of the cuvette table 15.

The second sample dispensing unit 22 aspirates a sample contained in acuvette at a sample aspirating position 19, or a sample in a samplecontainer 61 located at a predetermined sample aspirating position 54 inthe transportation area of the transport path 51. The sample aspiratedby the second sample dispensing unit 22 is discharged into a cuvette setin the cuvette transporter 32. It should be noted that the second sampledispensing unit 22 can aspirate a diluent set in the diluent transporter33. In this case, the sample dispensing unit 22 aspirates the diluent ata diluent aspirating position 37 before aspirating a sample, and thenaspirates the sample at the sample aspirating position 19 or 54.

In the case where a measurement order including a plurality ofmeasurement items for one sample has been obtained, the sample in thecuvette set in a cuvette holding hole 15 a in the cuvette table 15 issubdivided into cuvettes, the number of the cuvettes corresponding tothe number of measurement items. Each cuvette corresponds to onemeasurement item, and the subdivided sample in a cuvette is measured forthe measurement item corresponding to that cuvette.

When the sample has been discharged (subdivided) into the cuvettes thathave been accommodated in the cuvette transporter 32, the cuvettetransporter 32 is driven rightward on the rail at a predeterminedtiming. Subsequently, a cuvette containing the sample set in the cuvettetransporter 32 is gripped by the first catcher unit 26, and then set ina cuvette holding hole 16 a in the heating table 16. The samplecontained in the cuvette is heated for a time period corresponding toits measurement item in the heating table 16. For example, in the casewhere the measurement item is PT, the sample is heated for 3 minutes,and in the case where the measurement item is APTT, the sample is heatedfor 1 minute.

After the sample has been heated, a reagent is mixed into the sample.Whether the sample mixed with the reagent is measured by the detectionunit 40 or heated again differs depending on the measurement item. Forexample, in the case where the measurement item is PT, a PT reagent isdispensed in the cuvette containing the heated sample, and then theresultant mixture is subjected to optical measurement in the detectionunit 40.

In this case, the cuvette held in the cuvette holding hole 16 a in theheating table 16 is gripped by the third catcher unit 28, and thenlocated at a reagent discharging position 39 a or 39 b. Here, the secondreagent dispensing unit 24 or the third reagent dispensing unit 25aspirates a reagent in a predetermined reagent container 200 placed onthe first reagent table 11 or the second reagent table 12, anddischarges the reagent at the reagent discharging position 39 a or 39 b.Then, after the reagent has been discharged, the third catcher unit 28sets the cuvette, into which the reagent has been discharged, in aholding hole 41 in the detection unit 40. Then, optical information ofthe measurement specimen contained in the cuvette is detected by thedetection unit 40.

The case where the heated sample is mixed with a reagent and theresultant mixture is heated again will be described. In the case of ameasurement item for which the sample is heated twice in this manner,the sample is heated for a predetermined time period in the heatingtable 16, and the second catcher unit 27 grips the cuvette containingthe sample set in the holding hole 16 a and moves it to a reagentdischarging position 38. Here, the first reagent dispensing unit 23aspirates a reagent in a predetermined reagent container 200 placed onthe first reagent table 11 or the second reagent table 12, anddischarges the reagent at the reagent discharging position 38. After thereagent has been discharged, the second catcher unit 27 agitates thecuvette and sets it in a cuvette holding hole 16 a in the heating tableagain.

The cuvette held in the cuvette holding hole 16 a in the heating table16 is gripped by the third catcher unit 28, and then located at thereagent discharging position 39 a or 39 b. Here, the second reagentdispensing unit 24 or the third reagent dispensing unit 25 aspirates areagent in a predetermined reagent container 200 placed on the firstreagent table 11 or the second reagent table 12, and discharges thereagent at the reagent discharging position 39 a or 39 b. After thereagent has been discharged, the third catcher unit 28 sets the cuvette,into which the reagent has been discharged, in a holding hole 41 in thedetection unit 40. Then, optical information of the measurement specimencontained in the cuvette is detected by the detection unit 40.

Measurement data (optical information) obtained by the detection unit 40is transmitted to the information processing unit 4. The informationprocessing unit 4 reads data of a calibration curve for thecorresponding measurement item from the hard disk 404, and converts themeasurement data by using the calibration curve. The convertedmeasurement data is regarded as the final measurement result, and isstored in association with the sample information such as the sample ID,in a measurement result database (not shown) provided in the hard disk404. Further, the measurement result is displayed on the display unit409.

The cuvette for which detection by the detection unit 40 has been endedand which is no more needed is moved, being gripped by the third catcherunit 28, to a position directly above the disposal hole 35, and isdiscarded into the disposal hole 35. Also with respect to the cuvetteheld in a cuvette holding hole 15 a in the cuvette table 15, whenanalysis therefor has been ended and the cuvette is no more needed, thecuvette table 15 is rotated and the cuvette is located at a positionnear the second catcher unit 27. The second catcher unit 27 grips thecuvette which is held in the cuvette holding hole 15 a and is no moreneeded, and discards it into a disposal hole 36.

<Calibration Operation for Sample Analyzer>

Next, a calibration operation for the sample analyzer 2 will bedescribed. FIG. 9 is a flow chart showing the flow of a calibrationoperation for the sample analyzer performed in the management systemaccording to the present embodiment. The sample analyzer 2 measures aquality control substance in quality control, and when the measurementresult is outside a limitation range for the quality control, the sampleanalyzer 2 detects this as abnormality. The CPU 401 detects this eventof the detection of the abnormality, which is used by the sampleanalyzer 2 as a trigger for starting self-adjustment. In this manner,when abnormality has been detected in the sample analyzer 2 (step S101),the CPU 401 of the information processing unit 4 transmits, to themanagement server 5, self-adjustment approval request data including theauthentication ID of the sample analyzer 2 stored in the hard disk 404and abnormality information regarding the abnormality that has occurred(step S102). The abnormality information includes the date and time whenthe abnormality occurred, the type of the abnormality (in the abovecase, successive abnormalities in measurement results), data regardingthe abnormality (such as measurement results), information of an errorthat occurred in the same time period in which the abnormality occurred,and the like.

The management server 5 receives the self-adjustment approval requestdata (step S103). The CPU 501 of the management server 5 determineswhether to permit self-adjustment based on the received self-adjustmentapproval request data (step S104). The process of determining whether topermit the self-adjustment is performed by determining whether thereceived authentication ID is not an unauthorized one, and by checkingwhether the maintenance service under contract with the user includesself-adjustment of the sample analyzer. When the self-adjustment is notpermitted (NO in step S104), the CPU 501 transmits, to the clientapparatus 6, notification data that includes, for example, informationspecifying the sample analyzer in which the abnormality has occurred(apparatus ID, model name, facility name, and the like) and informationindicating the type of the abnormality, or information indicating thatan unauthorized access has occurred, thereby notifying a technician ofoccurrence of abnormality or occurrence of an unauthorized access (stepS105). Accordingly, when notification of occurrence of abnormality hasbeen made, a technician makes a telephone call to the user or visits thefacility, whereby measures for eliminating the abnormality are taken.When notification of occurrence of an unauthorized access has been made,a technician contacts a security department or the like of themaintenance service provider, for example, whereby necessary measuresagainst the unauthorized access are taken.

In step S104, when the self-adjustment has been permitted (YES in stepS104), the CPU 501 transmits, to the sample analyzer 2, self-adjustmentpermission data indicating that the self-adjustment has been permitted(step S106). The self-adjustment permission data includes informationnecessary for performing a self-adjustment operation, such as the typeof the self-adjustment, that is, information indicating generation of acalibration curve, information indicating a measurement item for whichthe calibration curve is to be generated, and the like.

The CPU 401 of the information processing unit 4 determines whether theself-adjustment permission data has been received (step S107). When theself-adjustment permission data has not been received (NO in step S107),the CPU 401 ends the process. On the other hand, when theself-adjustment permission data has been received (YES in step S107),the CPU 401 performs a calibration curve generation process (step S108).

Here, the calibration curve generation process will be described. Theinformation processing unit 4 can cause a display unit 420 to displayguidance information that explains the procedure of generating acalibration curve. In the calibration curve generation process, the CPU401 causes the display unit 420 to display the guidance information. Theuser performs a calibration curve generation operation in accordancewith the instruction by the guidance information.

First, the guidance information instructs the user to preparecalibrators. A calibrator is a standard substance having a knownmeasurement value for a measurement item for which a calibration curveis to be generated. Hereinafter, the known measurement value of acalibrator will be referred to as a “calibration value”. In the presentembodiment, five calibrators respectively having different calibrationvalues are used for generating a calibration curve. The user preparesfive calibrators, causes a sample rack 60 to hold five sample containers61 containing the respective calibrators in accordance with the guidanceinformation, and sets the sample rack 60 in the pre-analysis rackholding area of the transport path 51. In this state, the user gives theinformation processing unit 4 an instruction to measure the calibrators.

When the instruction to measure the calibrators is given to the sampleanalyzer 2, the measurement unit 3 measures, in a similar procedure tothe sample analysis procedure described above, each calibrator for themeasurement item for which generation of a calibration curve has beeninstructed in the self-adjustment permission data. Measurement data(optical information) obtained by the detection unit 40 is provided tothe information processing unit 4.

The CPU 401 of the information processing unit 4 generates a calibrationcurve for converting the measurement values of the respectivecalibrators provided from the detection unit 40 into the respectivecalibration values of the calibrators. The CPU 401 transmits, to themanagement server 5, calibration curve change approval request dataincluding the authentication ID, the measurement values and thecalibration values of the respective calibrators, and the generatedcalibration curve (step S109).

The management server 5 receives the calibration curve change approvalrequest data (step S110). Based on the received calibration curve changeapproval request data, the CPU 501 of the management server 5 determineswhether to permit calibration curve change (step S111). Whether topermit the calibration curve change is determined by determining whetherthe received authentication ID is not an unauthorized one, and bychecking whether the maintenance service under contract with the userincludes self-adjustment of the sample analyzer, and in addition, basedon whether the measurement values of the calibrators included in thecalibration curve change approval request data are within an acceptablerange defined based on the calibration values of the calibrators. Thatis, when the measurement values are within the acceptable range, thecalibration curve change is permitted, and when the measurement valuesare outside the acceptable range, the calibration curve change is notpermitted.

When the calibration curve change is not permitted (NO in step S111),the CPU 501 transmits, to the client apparatus 6, notification data thatincludes, for example, information specifying the sample analyzer inwhich the abnormality has occurred (apparatus ID, model name, facilityname, and the like) and information indicating the type of theabnormality, or information indicating that an unauthorized access hasoccurred, thereby notifying a technician of occurrence of abnormality oroccurrence of an unauthorized access (step S105). Accordingly, whennotification of occurrence of abnormality has been made, a technicianmakes a telephone call to the user or visits the facility, wherebymeasures for eliminating the abnormality are taken. When notification ofoccurrence of an unauthorized access has been made, a techniciancontacts a security department or the like of the maintenance serviceprovider, for example, whereby necessary measures against theunauthorized access are taken.

In step S111, when the calibration curve change has been permitted (YESin step S111), the CPU 501 transmits, to the sample analyzer 2,calibration curve change permission data indicating that the calibrationcurve change has been permitted (step S112), and ends the process.

The CPU 401 of the information processing unit 4 determines whether thecalibration curve change permission data has been received (step S113).When the calibration curve change permission data has not been received(NO in step S113), the CPU 401 ends the process. On the other hand, whenthe calibration curve change permission data has been received (YES instep S113), the CPU 401 changes the calibration curve stored in the harddisk 404 to the calibration curve generated in step S108 (step S114),and ends the process. Thus, the self-adjustment (generation of acalibration curve) of the sample analyzer 2 is completed.

<Pipette Position Adjustment Operation>

Next, a pipette position adjustment operation performed in the sampleanalyzer 2 will be described. FIG. 10 is a flow chart showing the flowof a pipette position adjustment operation performed in the managementsystem according to the present embodiment. It should be noted that thecase where the pipette position of the first reagent dispensing unit 23is adjusted will be described here, but the pipette position in each ofthe first sample dispensing unit 21, the second sample dispensing unit22, the second reagent dispensing unit 24, and the third reagentdispensing unit 25 is also adjusted through a similar operation.

The sample analyzer 2 can detect that a pipette has collided with anobstacle such as the wall of a cuvette, by means of the collisiondetection sensor section 323. In the case where the pipette P of thefirst reagent dispensing unit 23 dispenses a reagent into a cuvettelocated at the reagent discharging position 38, the pipette P havingaspirated the reagent from a reagent container is caused to ascend, thearm 23 b is then rotated by the driving section 23 a, and the pipette Pis positioned at the reagent discharging position 38. Subsequently, thepipette P is moved downward, and the tip of the pipette P is insertedinto the cuvette. Here, due to displacement of the pipette P over time,or the like, in the case where the pipette P is not accuratelypositioned at the reagent discharging position 38, the pipette P willcontact the wall of the cuvette or the like when the pipette P descends.Such a collision of the pipette P with an obstacle is detected by thecollision detection sensor 170.

In this manner, when abnormality has been detected by the sampleanalyzer 2 (step S201), the CPU 401 of the information processing unit 4transmits to the management server 5 self-adjustment approval requestdata including the authentication ID of the sample analyzer 2 stored inthe hard disk 404 and abnormality information regarding the abnormalitythat has occurred (step S202). The abnormality information includes thedate and time when the abnormality occurred, the type of the abnormality(in the above case, abnormality in the stop position of the pipette ofthe first reagent dispensing unit 23), data regarding the abnormality(such as an image taken by the camera 23 d when the abnormality wasdetected), information of an error that occurred in the same time periodin which the abnormality occurred, and the like.

The management server 5 receives the self-adjustment approval requestdata (step S203). Based on the received self-adjustment approval requestdata, the CPU 501 of the management server 5 determines whether topermit self-adjustment (step S204). The process of determining whetherto permit the self-adjustment is performed by determining whether thereceived authentication ID is not an unauthorized one, and by checkingwhether the maintenance service under contract with the user includesself-adjustment of the sample analyzer. When the self-adjustment is notpermitted (NO in step S204), the CPU 501 transmits, to the clientapparatus 6, notification data that includes, for example, informationspecifying the sample analyzer in which the abnormality has occurred(apparatus ID, model name, facility name, and the like) and informationindicating the type of the abnormality, or information indicating thatan unauthorized access has occurred, thereby notifying a technician ofoccurrence of abnormality or occurrence of an unauthorized access (stepS205). Accordingly, when notification of occurrence of abnormality hasbeen made, a technician makes a telephone call to the user or visits thefacility, whereby measures for eliminating the abnormality are taken.When notification of occurrence of an unauthorized access has been made,a technician contacts a security department or the like of themaintenance service provider, for example, whereby necessary measuresagainst the unauthorized access are taken.

In step S204, when the self-adjustment has been permitted (YES in stepS204), the CPU 501 transmits, to the sample analyzer 2, self-adjustmentpermission data indicating that self-adjustment has been permitted (stepS206). The self-adjustment permission data includes informationnecessary for performing a self-adjustment operation, such as the typeof the self-adjustment, that is, information indicating pipette positionadjustment for the first reagent dispensing unit 23, and the like.

The CPU 401 of the information processing unit 4 determines whether theself-adjustment permission data has been received (step S207). When theself-adjustment permission data has not been received (NO in step S207),the CPU 401 ends the process. On the other hand, when theself-adjustment permission data has been received (YES in step S207),the CPU 401 performs an adjustment amount detection process (step S208).

Here, the adjustment amount detection process will be described. FIG. 11is a flow chart showing the procedure of the adjustment amount detectionprocess. First, the CPU 401 controls the driving section 23 a for thefirst reagent dispensing unit 23 to cause the pipette P to ascend to anupper limit position, and then causes the arm 23 b to rotate, and causesthe pipette P to move to the reagent discharging position 38 (stepS301). The positional information of the reagent discharging position 38is stored in the hard disk 404, as a moving amount (the pulse number ofthe rotation motor 231) of the arm 23 b from its origin position to thereagent discharging position 38. That is, in step S301, by rotating thearm 23 b from the origin position by the set moving amount, the pipetteP is moved to the reagent discharging position 38. It should be notedthat in the case where the position at which position adjustment shouldbe performed is not the reagent discharging position 38 but a positionfor aspirating a reagent from a reagent container, the pipette P will bepositioned at that position.

Next, the CPU 401 causes the camera 23 d to take an image of the cuvetteat the reagent discharging position 38 and obtains the image of thecuvette (step S302). At this time, when the cuvette is not at thereagent discharging position 38, the second catcher unit 27 is driven toposition the cuvette at the reagent discharging position 38.

FIG. 12 is a schematic diagram showing an image of a cuvette when thepipette has not been displaced, and FIG. 13 is a schematic diagramshowing an example of an image of a cuvette when the pipette has beendisplaced. The camera 23 d is attached to the arm 23 b such that thepipette P is always located at the middle in the left-right direction inan imaging area. As shown in FIG. 12, when the pipette has not beendisplaced, the center C1 of the cuvette in its width direction coincideswith the center C0 of the image in the left-right direction. On theother hand, as shown in FIG. 13, when the pipette has been displaced,the center C1 of the cuvette in its width direction does not coincidewith the center C0 of the image in the left-right direction. That is,the pipette P has been displaced by the distance D between the center C0and the center C1. Moreover, the center C0 of the image is also thecenter position of the pipette P. Therefore, it is sufficient that theposition of the pipette is adjusted by an adjustment amount that is thedistance D, in a direction from the center C0 to the center C1.

The CPU 401 detects the center C1 of the cuvette in the width directionthrough image processing (step S303). Specifically, with respect to apredetermined pixel string extending in the horizontal direction of theimage taken by the camera 23 d (hereinafter, referred to as “cuvetteimage”), the image being a gradation image, the CPU 401 differentiatesthe pixel data (brightness values). The portion corresponding to thewall of the cuvette has higher brightness than the background. Thus,when differentiation is performed from left to right, derivative valuesbecome abruptly high at the boundary between the background and the wallof the cuvette at its left side, and derivative values become abruptlylow at the boundary between the wall of the cuvette at its right sideand the background. The CPU 401 detects a peak of the derivative valuesat the boundary between the background and the wall of the cuvette atits left side by using a predetermined positive first threshold value,and detects a peak of the derivative values at the boundary between thewall of the cuvette at its right side and the background by using apredetermined negative second threshold value. Further, the CPU 401determines the middle position between the detected two peak positions,and sets this position as the center C1 of the cuvette in the widthdirection.

It should be noted that the image processing for determining theposition of the center C1 of the cuvette in the width direction is notlimited to the above method. The position of the wall of the cuvette maybe detected by binarizing the cuvette image, or the position of thecuvette may be detected through pattern matching.

Next, the CPU 401 calculates an adjustment direction and an adjustmentamount of the position of the pipette, based on the detected center C1and the center C0 of the cuvette image (step S304). Specifically, whenthe direction from the center C0 to the center C1 is the rightdirection, the CPU 401 defines the clockwise direction in the rotationdirection of the arm 23 b as the adjustment direction. When thedirection from the center C0 to the center C1 is the left direction, theCPU 401 defines the counter-clockwise direction in the rotationdirection of the arm 23 b as the adjustment direction. Further, therelationship between the distance D and the pulse number of the rotationmotor 231 is stored in the hard disk 404, and thus, the CPU 401 derives,as an adjustment amount, a corresponding pulse number from the distanceD between the center C0 and the center C1 detected in step S303.

After the process in step S304, the CPU 401 returns the process to theaddress for calling the adjustment amount detection process in the mainroutine.

After the adjustment amount detection process ends, the CPU 401transmits, to the management server 5, pipette position adjustmentapproval request data including the authentication ID and the detectedadjustment direction and adjustment amount (step S209).

The management server 5 receives the pipette position adjustmentapproval request data (step S210). The CPU 501 of the management server5 determines whether to permit pipette position adjustment, based on thereceived pipette position adjustment approval request data (step S211).Whether to permit the pipette position adjustment is determined bydetermining whether the received authentication ID is not anunauthorized one, and by checking whether the maintenance service undercontract with the user includes self-adjustment of the sample analyzer,and in addition, based on whether the adjustment amount included in thepipette position adjustment approval request data is within apredetermined acceptable range. That is, when the adjustment amount iswithin the acceptable range, the pipette position adjustment ispermitted, and when the adjustment amount is outside the acceptablerange, the pipette position adjustment is not permitted.

When the pipette position adjustment is not permitted (NO in step S211),the CPU 501 transmits, to the client apparatus 6, notification data thatincludes, for example, information specifying the sample analyzer inwhich the abnormality has occurred (apparatus ID, model name, facilityname, and the like) and information indicating the type of theabnormality, or information indicating that an unauthorized access hasoccurred, thereby notifying a technician of occurrence of abnormality oroccurrence of an unauthorized access (step S205). Accordingly, whennotification of occurrence of abnormality has been made, a technicianmakes a telephone call to the user or visits the facility, wherebymeasures for eliminating the abnormality are taken. When notification ofoccurrence of an unauthorized access has been made, a techniciancontacts a security department or the like of the maintenance serviceprovider, for example, whereby necessary measures against theunauthorized access are taken.

In step S211, when the pipette position adjustment has been permitted(YES in step S211), the CPU 501 transmits, to the sample analyzer 2,pipette position adjustment permission data indicating that the pipetteposition adjustment has been permitted (step S212), and ends theprocess.

The CPU 401 of the information processing unit 4 determines whether thepipette position adjustment permission data has been received (stepS213). When the pipette position adjustment permission data has not beenreceived (NO in step S213), the CPU 401 ends the process. On the otherhand, when the pipette position adjustment permission data has beenreceived (YES in step S213), the CPU 401 adjusts the pipette position inthe adjustment direction and by the adjustment amount detected in stepS208 (step S214), and ends the process. In step S214, the pipetteposition adjustment is performed by updating the positional informationof the reagent discharging position 38 stored in the hard disk 404 withthe adjustment direction and the adjustment amount detected in stepS208. That is, when the rotation direction of the rotation motor 231 forrotating the arm 23 b from its origin position to the reagentdischarging position 38 is the same as the adjustment direction, theadjustment amount is added to the positional information (the pulsenumber of the rotation motor 231) stored in the hard disk 404. When therotation direction of the rotation motor 231 for rotating the arm 23 bfrom its origin position to the reagent discharging position 38 isopposite to the adjustment direction, the adjustment amount issubtracted from the positional information stored in the hard disk 404.In this manner, pipette position adjustment is performed. As a result,the self-adjustment (pipette position adjustment) of the sample analyzer2 is completed.

According to the above configuration, the management system according tothe present embodiment does not require complicated operations, such asa technician determining a command for remote-controlling the sampleanalyzer 2 and transmitting it to the sample analyzer 2, and thus,alleviates the burden on the technician, when compared with conventionalmanagement systems. Further, an adjustment amount due to an individualdifference of the sample analyzer 2 is automatically detected, and thisadjustment amount allows self-adjustment of the sample analyzer 2.Therefore, it is possible to perform appropriate adjustment for eachsample analyzer. Further, if the sample analyzer 2 performs theself-adjustment on its own, based on determination by itself, whetherappropriate adjustment is performed is not known, and thus reliabilityof measurement results cannot be ensured. The management systemaccording to the present embodiment is configured such that, unlessapproval by the management server 5 is obtained, the sample analyzer 2cannot perform the self-adjustment. Therefore, the sample analyzer 2 canperform the self-adjustment only when adjustment thereof is necessary,and thus, reliability of measurement results by the sample analyzer 2 isnot impaired.

Embodiment 2

The configuration of a management system according to the presentembodiment is similar to that of the management system 1 according toembodiment 1. Therefore, the same components are denoted by the samereference characters, and description thereof will be omitted.

Next, operations performed by the management system according to thepresent embodiment will be described.

FIG. 14 is a flow chart showing the flow of a self-adjustment operationperformed by a sample analyzer according to the present embodiment. Whenthe sample analyzer 2 has detected abnormality, the CPU 401 detects theevent of this detection of the abnormality, which is used as a triggerfor the self-adjustment operation. The abnormality includes the qualitycontrol abnormality and the pipette drive abnormality as described inembodiment 1 above, and the like.

As described above, when abnormality has been detected in the sampleanalyzer 2 (step S401), the CPU 401 of the information processing unit 4determines the type of the detected abnormality (step S402).Abnormalities that occur in the sample analyzer 2 include abnormalitythat greatly affects a sample analysis result, and abnormality thatscarcely affects a sample analysis result. For example, abnormality in aquality control result may require re-generation of the calibrationcurve, and this directly affects a sample analysis result. On the otherhand, abnormality relating to mechanical arrangement or drive, such aspipette drive failure, bar code reading abnormality, and catcher driveabnormality, scarcely affects a sample analysis result. In the processof step S402, it is determined whether the abnormality detected in stepS401 is abnormality that greatly affects a sample analysis result(hereinafter referred to as “first type abnormality”) or abnormalitythat scarcely affects a sample analysis result (hereinafter referred toas “second type abnormality”). More specifically, in the hard disk 404,with respect to each abnormality, information indicating that theabnormality is the first type abnormality or the second type abnormalityis stored in association with a corresponding error code. Whenabnormality has been detected, the above information in the hard disk404 is referred to, and which of the first type abnormality and thesecond type abnormality corresponds to the error code of the detectedabnormality is specified.

In step S402, when it has been determined that the type of the detectedabnormality is the first type (“first type” in step S402), the CPU 401transmits self-adjustment approval request data to the management server5 (step S403). The management server 5 receives the self-adjustmentapproval request data and determines whether to permit self-adjustment.When permitting the self-adjustment, the management server 5 transmitsself-adjustment permission data to the sample analyzer 2, and when notpermitting the self-adjustment, the management server 5 notifies atechnician of occurrence of abnormality or occurrence of an unauthorizedaccess. It should be noted that the operation performed by themanagement server 5 is similar to the operation performed by themanagement server 5 described in embodiment 1, and therefore, detaileddescription thereof is omitted here.

The CPU 401 of the information processing unit 4 determines whether theself-adjustment permission data has been received (step S404). When theself-adjustment permission data has not been received (NO in step S404),the CPU 401 ends the process. On the other hand, when theself-adjustment permission data has been received (YES in step S404),the CPU 401 performs a self-adjustment process (step S405). Theself-adjustment process is a process of determining an adjustment valuefor eliminating the first type abnormality described above, and is, forexample, the process of generating a calibration curve described inembodiment 1.

When the self-adjustment process has been ended, the CPU 401 transmits,to the management server 5, change approval request data including theauthentication ID and the adjustment value obtained through theself-adjustment process (step S406). The management server 5 receivesthe change approval request data and determines whether to permit changefrom the adjustment value set in the sample analyzer 2 to a newadjustment value. When permitting changing the adjustment value, themanagement server 5 transmits change permission data to the sampleanalyzer 2, and when not permitting changing the adjustment value, themanagement server 5 notifies a technician of occurrence of abnormalityor occurrence of an unauthorized access.

The CPU 401 of the information processing unit 4 determines whether thechange permission data has been received (step S407). When the changepermission data has not been received (NO in step S407), the CPU 401ends the process. On the other hand, when the change permission data hasbeen received (YES in step S407), the CPU 401 changes the adjustmentvalue stored in the hard disk to the adjustment value obtained throughthe self-adjustment process in step S405 (step S409), and ends theprocess.

Next, a case where the detected abnormality is the second typeabnormality will be described. When it has been determined that the typeof the detected abnormality is the second type in step S402 (“secondtype” in step S402), the CPU 401 does not request approval forself-adjustment from the management server 5, and performs aself-adjustment process (step S408). The self-adjustment process is aprocess for determining an adjustment value for eliminating the secondtype abnormality described above, and is, for example, the process ofdetecting a pipette position adjustment amount described inembodiment 1. In the case where the abnormality detected in step S401 isa bar code reading abnormality, a position adjustment amount for the barcode reader 31 is detected in the self-adjustment process. In the casewhere the abnormality detected in step S401 is a catcher driveabnormality, a position adjustment amount for the grip portion or thelike of the catcher unit where the abnormality has occurred is detected.

When the adjustment value is obtained through the self-adjustmentprocess, the CPU 401 changes the adjustment value stored in the harddisk to the adjustment value obtained through the self-adjustmentprocess in step S405 (step S409), and ends the process.

In the above configuration, the management system according to thepresent embodiment requires approval by the management server 5 withrespect to a self-adjustment that greatly affects a sample analysisresult, and thus, it is possible to carefully perform theself-adjustment. Further, with respect to a self-adjustment thatscarcely affects a sample analysis result, approval by the managementserver 5 is not required, and thus, it is possible to easily perform theself-adjustment.

Other Embodiments

In the above embodiments, the sample analyzer 2 having a self-adjustmentfunction is a blood coagulation measurement apparatus. However, thepresent invention is not limited thereto. It may be configured such thata sample processing apparatus which processes samples, such as a bloodcell counter, an immune analyzer, a gene amplification measurementapparatus, a biochemical analyzer, a urine qualitative analyzer, a urineformed element analyzer, or a blood smear preparation apparatus,performs self-adjustment.

Further, in the above embodiments, a configuration has been described inwhich self-adjustment is started by using an event of detection ofabnormality as a trigger. However, the present invention is not limitedthereto. Specifically, an operator manually inputs a predeterminedcommand key provided in the sample analyzer, and the event of inputtingthis command is detected by the CPU 401 of the information processingunit 4, whereby instruction to start self-adjustment may be given. Whenan event in which the sample analyzer satisfies a predeterminedcondition has occurred (for example, when the number of analysisoperations performed by the sample analyzer has reached a predeterminednumber, when the operating time period has reached a predetermined timeperiod, or when a predetermined time period has elapsed since thepreceding self-adjustment was performed), the CPU 401 of the informationprocessing unit 4 detects the event, whereby self-adjustment may bestarted. Further, an apparatus, such as a management server, connectedto a sample analyzer transmits to the sample analyzer a command thatgives instruction to start self-adjustment, and the CPU 401 of theinformation processing unit 4 detects the event of receiving thecommand, whereby self-adjustment may be started.

Further, in the above embodiments, as a self-adjustment function of thesample analyzer 2, a configuration has been described in which thesample analyzer 2 performs generation of a calibration curve or positionadjustment of a pipette that dispenses a reagent or a sample. However,the present invention is not limited thereto. Self-adjustment of othermechanisms may be performed. For example, it may be configured suchthat: a camera is attached to the tip of the arm of each of the firstcatcher unit to the third catcher unit so as to be able to take an imageof the grip portion; and when a cuvette gripping failure by the gripportion has occurred, the camera takes an image of the grip portionwhere the cuvette gripping failure has occurred, and position adjustmentof the grip portion is performed. Further, it may be configured suchthat: the bar code reader 31 is provided with an actuator such as astepping motor to allow position adjustment; and when a bar code readingfailure by the bar code reader has occurred, self-adjustment of theposition of the bar code reader is performed.

Further, in the case where the sample analyzer having a self-adjustmentfunction is configured to convert measurement data by using a set ofcalibration values and measurement values, such as in the case of ablood cell counter, a urine formed element analyzer, or the like,self-adjustment may be performed not by generating a calibration curvebut by generating a conversion constant therefor.

Further, in the above embodiments, calibration for which the managementserver 5 automatically gives approval for self-adjustment has beendescribed. However, the present invention is not limited thereto. It maybe configured such that: the management server 5 transmits to the clientapparatus 6 data for requesting approval for self-adjustment of thesample analyzer 2, and the client apparatus 6 requests approval for theself-adjustment from a technician in charge of maintenance; and when theapproval has been obtained from the technician, the client apparatus 6transmits self-adjustment permission data to the sample analyzer 2,thereby allowing the sample analyzer 2 to perform the self-adjustment.

The sample processing apparatus management system, the sample processingapparatus and the management apparatus according to the presentinvention are useful as a management system for a sample processingapparatus which process samples such as blood and urine, a sampleprocessing apparatus, a management apparatus, and the like.

The invention claimed is:
 1. A managing method for operating a sampleprocessing apparatus using a management apparatus, the methodcomprising: submitting a request from the sample processing apparatus tothe management apparatus for approval of a self-adjustment of the sampleprocessing apparatus before performing the self-adjustment; uponapproving the sample processing apparatus to perform theself-adjustment, informing the sample processing apparatus of approvalof request from the management apparatus; determining an adjustment bythe sample processing apparatus and submitting the adjustment to themanagement apparatus requesting approval; upon receipt of the adjustmentfrom the sample processing apparatus, determining by the managementapparatus if the adjustment is approvable; upon approving theadjustment, informing the sample processing apparatus of approval of theadjustment from the management apparatus; and performing, at the sampleprocessing apparatus, the self-adjustment based on the adjustmentapproved by the management apparatus in response to the approval.
 2. Themanagement method according to claim 1, further comprising: detecting anevent for starting the self-adjustment by the sample processingapparatus, wherein the request of approval is made when the event isdetected.
 3. The management method according to claim 2, whereindetecting the event includes detecting an abnormality in the sampleprocessing apparatus.
 4. The management method according to claim 2,further comprising: determining a type of the event by the sampleprocessing apparatus, wherein, when the type of the event is a type ofan event for which the self-adjustment should be performed withoutwaiting for the approval, the sample processing apparatus performs theself-adjustment without waiting for the approval.
 5. The managementmethod according to claim 1, wherein the sample processing apparatus isprovided in a hospital or a test center.
 6. The management methodaccording to claim 1, wherein the management apparatus is provided in amaintenance service provider facility.
 7. The management methodaccording to claim 1, wherein the management apparatus is connected to aplurality of sample processing apparatuses.
 8. The management methodaccording to claim 1, wherein the management apparatus is connected to aclient apparatus that is communicably connected the managementapparatus.
 9. A method for managing self-adjustment of a sampleprocessing apparatus by a management server, the method comprising:receiving, at the management apparatus, an approval request for theself-adjustment from a sample processing apparatus; determining, by themanagement apparatus, whether to permit the sample processing apparatusto perform the self-adjustment and communicating with the sampleprocessing apparatus to inform that the self-adjustment is permittedwhen the determination is positive; receiving at the managementapparatus an adjustment determined by the sample processing apparatus;and determining by the management apparatus whether the adjustment isapprovable and communicating with the sample processing apparatus toinform that the adjustment is approved when the determination ispositive, wherein the sample processing apparatus performs theself-adjustment based on the adjustment approved by the managementapparatus in response to an approval.
 10. The method for managingself-adjustment of a sample processing apparatus according to claim 9,wherein the sample processing apparatus is provided in a hospital or atest center.
 11. The method for managing self-adjustment of a sampleprocessing apparatus according to claim 9, wherein the managementapparatus is provided in a maintenance service provider facility. 12.The method for managing self-adjustment of a sample processing apparatusaccording to claim 9, wherein the management apparatus is connected to aplurality of sample processing apparatuses.
 13. The method for managingself-adjustment of a sample processing apparatus according to claim 9,wherein the management apparatus is connected to a client apparatus thatis communicably connected the management apparatus.
 14. The method formanaging self-adjustment of a sample processing apparatus according toclaim 9, wherein the management apparatus is configured to generate anadjustment value for the sample processing apparatus.
 15. Aself-adjustment method for a sample processing apparatus, comprising:determining an adjustment by the sample processing apparatus; sendingapproval request data requesting approval for a self-adjustment from thesample processing apparatus to the management apparatus; determining anadjustment by the sample processing apparatus and transmitting theadjustment to the management apparatus for approval; and performing theself-adjustment by the sample processing apparatus, after the sampleprocessing apparatus receives approval data from the managementapparatus indicating the adjustment is approved by the managementapparatus.
 16. The self-adjustment method for a sample processingapparatus according to claim 15, wherein the sample processing apparatusis provided in a hospital or a test center.
 17. The self-adjustmentmethod for a sample processing apparatus according to claim 15, whereinthe management apparatus is provided in a maintenance service providerfacility.
 18. The self-adjustment method for a sample processingapparatus according to claim 15, wherein the management apparatus isconnected to a plurality of sample processing apparatuses.
 19. Theself-adjustment method for a sample processing apparatus according toclaim 15, wherein the management apparatus is connected to a clientapparatus that is communicably connected the management apparatus. 20.The self-adjustment method for a sample processing apparatus accordingto claim 15, wherein the management apparatus is configured to generatean adjustment value for the sample processing apparatus.